For Immediate Release:

September 02, 2021

The following quote is attributed to Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research

“This week, the FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation. This achievement highlights the success of the Competitive Generic Therapy program, which was designed to encourage the development and marketing of generic drugs for products with little to no competition.

There has been incredible interest in the Competitive Generic Therapy program since its inception in 2017; hundreds of applicants have requested Competitive Generic Therapy designations, providing the ability for the FDA to approve more than 100 of these applications in less than four years, among a broad range of products and therapeutic areas.

Additionally, more than 80% of the first-approved applicants who were eligible for Competitive Generic Therapy exclusivity started marketing the drug within 75 days after FDA approval. This is a sign the program is achieving what we hoped—spurring both development and market availability of safe and effective generic drugs in areas of the market that previously had little to no competition, giving patients more affordable access to medicine.”

Additional Information

• The first Competitive Generic Therapy (CGT)-designated abbreviated new drug application (ANDA), also known as a generic drug application, was approved on August 8, 2018. The related guidance for industry, Competitive Generic Therapies, was published as a draft in February 2019 and finalized in March 2020. The guidance describes the process that generic drug applicants should follow to request designation of a drug as a CGT and the criteria for that designation, as well as additional information about the CGT program. 
• At the request of the ANDA applicant, the FDA may take steps to expedite the development and review of ANDAs for drugs that receive a CGT designation. These actions can include product development or pre-submission meetings with the agency to discuss scientific issues or questions, or the format and content of a future ANDA, as well as mid-review-cycle meetings regarding any issues identified during the FDA’s review.
• Additionally, applicants for drugs that receive a CGT designation may be eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT and meet certain other conditions. Under a special forfeiture rule for CGTs, the applicant must commercially market the CGT within 75 calendar days after the date of approval of its ANDA, or it will forfeit its exclusivity. This marketing exclusivity blocks approval of competitive ANDAs, but only begins when the first CGT product is marketed. This provides an incentive to market the CGT quickly after it is first approved.
• The CGT program is part of the FDA Drug Competition Action Plan, which seeks to foster generic competition and help address the high cost of drugs.